PI4 - A Trial Assessing Metformin to Prolong Gestation in Preterm Preeclampsia

PHASE3RecruitingINTERVENTIONAL
Enrollment

294

Participants

Timeline

Start Date

January 19, 2024

Primary Completion Date

July 31, 2027

Study Completion Date

July 31, 2029

Conditions
Preeclampsia
Interventions
DRUG

Metformin ER

Metformin ER, one gram three times daily taken orally. Once the participants have been recruited, they will start by taking one 500 mg tablet three times a day. If well tolerated it will be increased day two to a maximum of two tablets three times a day. Treatment will continue until delivery. If there are side effects that are not tolerable, the dose will be decreased and the participant will remain blinded. Each participant will keep a treatment diary and number of tablets taken will be documented by the participant or hospital staff. The study will not alter or interfere with treatment or care routinely given for preterm preeclampsia.

DRUG

Placebo

Placebo, two tablets three times daily taken orally. Once the participants have been recruited, they will start by taking one tablet three times a day. If well tolerated it will be increased day two to a maximum of two tablets three times a day. Treatment will continue until delivery. If there are side effects that are not tolerable, the dose will be decreased and the participant will remain blinded. Each participant will keep a treatment diary and number of tablets taken will be documented by the participant or hospital staff. The study will not alter or interfere with treatment or care routinely given for preterm preeclampsia.

Trial Locations (9)

14157

RECRUITING

Karolinska University Hospital Huddinge, Stockholm

17176

RECRUITING

Karolinska University Hospital Solna, Stockholm

75237

RECRUITING

Uppsala University Hospital, Uppsala

79129

RECRUITING

Falu Lasarett, Falun

416 85

RECRUITING

Sahlgrenska University Hospital, Gothenburg

581 85

RECRUITING

Linköping University Hospital, Linköping

221 85

RECRUITING

Skåne University Hospital, Lund

205 02

RECRUITING

Skåne University Hospital, Malmo

182 88

NOT_YET_RECRUITING

Danderyd Hospital, Stockholm

All Listed Sponsors
collaborator

The Swedish Research Council

OTHER_GOV

lead

Lina Bergman

OTHER